Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
Primary Purpose
Fatigue, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Exercise
Therapeutic Education
Therapeutic exercise-Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Physical Therapy Modalities, Breast Cancer Treatment, Exercise Therapy, Dyspnea
Eligibility Criteria
Inclusion Criteria:
- Women treated for breast cancer, completed at least 6 months before, with persistent fatigue.
- Women who do not present contraindications for physiotherapy and physical exercise (infection, metastasis, loco regional recurrence, cardiopulmonary disorders).
- Women who have read, understood and signed informed consent freely.
Exclusion Criteria:
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Sites / Locations
- Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Physical Exercise
Therapeutic Exercise-Physiotherapy
Arm Description
The protocol consists in: Physical Exercise according to their preferences. Therapeutic Education related to Health Habits and Physical Exercise.
The protocol consists in: Cardiovascular exercise. Force-Resistance Exercises of the principals muscle groups of the lower limbs, upper limbs and trunk. Muscle Stretches. Therapeutic Education related to Health Habits and Physical Exercise.
Outcomes
Primary Outcome Measures
Subjective assessment of perception of fatigue.
FACIT-FatigueScale (total score)
Secondary Outcome Measures
Subjective assessment of perception of dyspnoea
Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"
Distance in meters
Distance in meters during "6-Minutes Walking Test (6MWT)"
Pain Intensity
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02828189
Brief Title
Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
Official Title
Efficacy of Therapeutic Exercise in Modulating Cancer-Related Fatigue in Women After Breast Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of this study is to determine whether the proposed program of therapeutic exercise is effective in improving fatigue, more than the exercise unsupervised depending on their preferences, in women treated for breast cancer.
Detailed Description
Introduction: The prevalence of cancer-related fatigue in women treated for breast cancer is about 30% having significant effects in reducing their quality of life. There is evidence of the presence of sleep problems and immune response. Several studies claim that physical exercise is effective during and after treatment of the disease as it improves the quality of life, cardiorespiratory function, physical functioning and symptoms of fatigue although not always found significant differences between intervention groups exercises compared with a control group. Although the results of these studies are promising, generally present methodological biases as small sample size, absence of masking, heterogeneous groups, lack of monitoring short and long term and especially lack of specificity in relation to prescribed exercise ( frequency, intensity, time and type of exercise).
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:
An experimental group, where the participants will be treated with Therapeutic Exercise;
And a group where will be done Physical Exercise according their preferences.
Pre-intervention, immediate post-intervention, 3 and 6 months assessments will be made. The selection criteria will be: Adult women treated for breast cancer, completed at least 6 months before, with persistent fatigue. All participants must understand and sign freely Informed Consent.
Sample size: 40 women for each group.
Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the two groups in outcome variables between physical therapy examinations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Breast Cancer
Keywords
Physical Therapy Modalities, Breast Cancer Treatment, Exercise Therapy, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Exercise
Arm Type
Active Comparator
Arm Description
The protocol consists in:
Physical Exercise according to their preferences.
Therapeutic Education related to Health Habits and Physical Exercise.
Arm Title
Therapeutic Exercise-Physiotherapy
Arm Type
Experimental
Arm Description
The protocol consists in:
Cardiovascular exercise.
Force-Resistance Exercises of the principals muscle groups of the lower limbs, upper limbs and trunk.
Muscle Stretches.
Therapeutic Education related to Health Habits and Physical Exercise.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Other Intervention Name(s)
Exercise
Intervention Description
The patients were instructed to perform autonomous physical exercise program based preferences (progressive march on flat ground, dancing, cycling, etc.). They will receive written information. The program is 9 weeks with a frequency of 3 days per week and sessions about 50 minutes long.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Education
Other Intervention Name(s)
Hygienic and behavioral advises
Intervention Description
Individual Therapeutic Education about healthy habits and exercise on breast cancer.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise-Physiotherapy
Other Intervention Name(s)
Physiotherapy exercise
Intervention Description
Cardiovascular exercise
Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk.
Flexibilization exercises
Primary Outcome Measure Information:
Title
Subjective assessment of perception of fatigue.
Description
FACIT-FatigueScale (total score)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Subjective assessment of perception of dyspnoea
Description
Borg Dyspnoea Test before and after "6-Minutes Walking Test (6MWT)"
Time Frame
6 months
Title
Distance in meters
Description
Distance in meters during "6-Minutes Walking Test (6MWT)"
Time Frame
6 months
Title
Pain Intensity
Description
Visual analogue scale (VAS).100 mm horizontal with pain descriptors marked "no pain" on the left side or "worst imaginable pain".
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women treated for breast cancer, completed at least 6 months before, with persistent fatigue.
Women who do not present contraindications for physiotherapy and physical exercise (infection, metastasis, loco regional recurrence, cardiopulmonary disorders).
Women who have read, understood and signed informed consent freely.
Exclusion Criteria:
Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Prieto Go´mez, PhD Student
Organizational Affiliation
University of Alcalá
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Therapeutic Exercise in Cancer-Related Fatigue in Women After Breast Cancer Treatment
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